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					                INSTITUTIONAL MEMBERSHIP APPLICATION CHECKLIST


Your complete application package must include the following documents:

       Completed Membership Application

       Federalwide Assurance (FWA) Number and Expiration Date

       Laboratory Certifications

       Curriculum Vitae (CV) (required for all investigators)

       Radiation Therapy Facilities Inventory (if applicable)

       Site Staff Information Form (required for all participating staff)

       Certification of Protection of Human Subject Training (required for all investigators)

       Signed AMC Statement of Financial, Equity, and Intellectual Property Interests (original copy
       required for primary investigator)

       Signed Adherence Statement (original copy required for primary investigator)



APPLICATION TYPE (please check one):

       Affiliated Site (Annual Accrual Required - 3)

       Enrolling Site (Annual Accrual Required - N/A)


                   Submit this completed checklist and the requested documentation to:
                                 AMC Operations and Data Management Center
                                    Attn: AMC Regulatory Coordinator
                                         The EMMES Corporation
                                    401 N. Washington Street, Suite 700
                                           Rockville, MD 20850

                            Email application questions to: amcpm@emmes.com.




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                                          SITE DEFINITIONS

Affiliated Site

Affiliated Sites are defined as those sites that wish to participate in the scientific deliberations of the
AMC and register subjects to AMC studies but do not have base core site funding. Affiliated Sites may
seek re-designation as Core Sites at one time each year, with the time and criteria for application to be
established by the Membership Subcommittee. Unsatisfactory performance or no accrual of subjects in
any year may result in loss of affiliated status.

Affiliated Sites must accrue a minimum of 3 subjects per grant year to AMC studies. Payment for
enrolled subjects will be based on a per capita basis and prorated based on key milestones in the protocol,
e.g. entry on the trial, completion of half of study visits, completion of end of study visit, etc. Accrual
payment will vary depending on the intensity of the study as determined by the appropriate Executive
Committee subcommittee. Cost reimbursement for specimen acquisition, storage and shipping and patient
incentives will be made on a per protocol basis.

PIs and other designated investigators at Affiliated Sites may perform the following functions for the
AMC:
   Serve as Working Group Chairs or Vice-chairs;
   Serve as Protocol Chairs/Co-Chairs or protocol development team members;
   Participate as a member of AMC Working Groups; and
   Be appointed as members of subcommittees of the Executive Committee.

Cost for travel to Group Meetings will be reimbursed for the Affiliated Site PIs upon designation by the
Group Chair and submission of a travel invoice to The EMMES Corporation.

Enrolling Site

Enrolling Sites are defined as those sites that have the necessary infrastructure and expertise to participate
in selected AMC trials. Enrolling Sites will be selected on a protocol-by-protocol basis and will generally
be established clinical trials units of the ACTG, INSIGHT or Cooperative Oncology Groups that have
agreed to collaborate on a joint or intergroup study. These Enrolling Sites will have been vetted by the
collaborating group and are known to or are certified to be capable of engaging in multicenter clinical
studies. They will receive credit for enrollment of patients from their primary affiliated group and will be
reimbursed on a capitated basis similar to that for Affiliated Sites.

There is no required minimum yearly number of subject enrollments for Enrolling Sites. Payment for
enrollment will be made centrally to the collaborating group for distribution to the Enrolling Sites as
appropriate. Investigators at the Enrolling Sites will be required to respond to data queries from the
participating collaborating group’s data management center, or from EMMES, as determined by the
specific needs of each protocol. Where appropriate, the data will be collected by the collaborating group’s
data management center and transferred to EMMES at specified intervals. Investigators at these Enrolling
Sites, with some exceptions, will not be the Protocol Chair and will not participate in the Executive
Committee or other deliberative bodies of the AMC or attend AMC group meetings.




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                                     MEMBERSHIP APPLICATION

Complete this application in proposal format where applicable to be reviewed by the AMC Executive
Committee. We prefer concise and convincing replies over length. Responses that address the questions
by presenting tabular information are encouraged. Do not refer the reviewer to documentation not
included in this application.

Institution Information

1. Legal Name of Institution:
   (Confirm the legal name with an institutional official)

2. Legal Address of Institution:

    City:                   State:           Zip + 4:

    Applications will be delayed until this information is provided. It is a NIH requirement.

3. Name of Academic Affiliation, if any:

4. Name of Principal or Responsible Investigator:

5. Is the Principal Investigator registered with CTEP?
   (Check one)

        Yes  If “Yes,” provide current CTEP investigator number:

        No        If “No,” please complete the required forms and submit them to CTEP’s Pharmaceutical
                   Management Branch. Do not submit CTEP Investigator Registration forms with this
                   application. Forms and instructions on CTEP Investigator Registration may be found at:
                   http://ctep.cancer.gov/investigatorResources/investigator_registration.htm

6. Name of Lead CRA:

7. Does your Institution currently partner with a local Community Advisory Board (CAB)?
   (Check one)

        Yes  If “Yes,” please provide the name of your site’s CAB representative and complete a site
              staff information form for the purpose of collecting contact information:

                   Briefly describe your site’s interactions and relationship with the CAB:

        No        If “No,” please be advised that a component of AMC member site evaluation includes
                   affiliation and communication with a CAB and that your site will need to establish a
                   relationship with a local CAB if approved as an AMC member institution.




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IRB Information
8. Specify IRB Name and Location:
    IRB registration number:
    Expiration date:

9. Does your institution have a current Federalwide Assurance (FWA)?
        Yes  If “Yes,” provide your current Assurance number, its expiration date, and a copy of the
              Assurance approval letter from the Office for Human Research Protections (OHRP)
                   Assurance number:
                   Expiration date:

        No        If “No,” please obtain a Federalwide Assurance from OHRP prior to submitting this
                   application. This form can be found on the OHRP website at:
                   http://www.hhs.gov/ohrp/assurances/assurances_index.html

Radiation Oncology Information
10. Will patients entered at this facility have access to Radiation Therapy?
    (Check one)
        Yes  If “Yes,” list below the name of each RT facility that will be used and attach a completed
              Radiation Therapy Facilities Inventory for each site:

        No

Laboratory Certification
Submit a copy of applicable laboratory certifications (CLIA certificate or equivalent) for your
institution’s local lab(s).


Site Personnel
Submit a Site Staff Information Form for each proposed staff member (investigators and support staff).
All Site Staff Information Forms for physicians must include their NCI Identification Number and NCI
Site Number.

Curriculum Vitae
Submit the curriculum vitae of each physician who plans to register patients.

Protection of Human Subject Training
Submit a certification of training on protection of human subjects for each participating investigator. If a
separate training course has not been completed, investigators may complete the NIH online Human
Subjects Training at http://phrp.nihtraining.com/users/login.php and provide a copy of the certificate with
this application.




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Membership Proposal
1. Describe the support resources available to assure timely compliance with AMC administrative and
   data requirements, e.g., oncology nurses, clinical research associates, administrative support for
   IRB requirements


2. Describe your pharmacy resources and how you plan to handle investigational drugs that are part
   of AMC research.


3. Describe your IRB review structure (i.e. central versus local, timing of review, etc.)


4. Document adequate patient resources available for entry into clinical trials. List your annual
   caseload of AIDS-related malignancies by disease and cite the source of the data (tumor registry,
   etc.).


5. Indicate anticipated accrual by types of studies (by disease). Specify any disease areas of AMC
   research in which you do NOT foresee participation.


6. Discuss any preclinical or other special resources which could benefit the AMC’s current scientific
   directions.


7. Describe your current cancer research programs and your HIV research programs. Describe your
   accruals to clinical trials for the past three years and cite accessibility rates of patients entered onto
   study. Any audit reports or monitoring reviews by outside reviewers could be attached as an
   appendix.


8. Describe any prior or current cancer research cooperative group experience of your institution.


9. Provide any other information that you feel is important to the review of this application.


Application submitted by/on:
Signature of Proposed PI: ________________________________                 Date:

                                   Return Completed Application to:
                                         AMC Operations Center
                                   Attn: AMC Regulatory Coordinator
                                        The EMMES Corporation
                                   401 N. Washington Street, Suite 700
                                          Rockville, MD 20850

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                                                                                             CONFIDENTIAL




                         RADIATION THERAPY FACILITIES INVENTORY

  NCI Site Number

  The AIDS Malignancy Clinical Trials Consortium (AMC) requires that the following information be collected
  for all facilities where patients enrolled in an AMC clinical trial are to receive radiation therapy.

   Radiation Therapy (Radiotherapy) Facility Name:

   Address:                                                  City:                      State:

   Country:                                                  Postal Code:

   Telephone:                      Ext:           Fax:                       Email:



  Radiation Oncology Personnel

  Chief of Radiation Oncology

   Name:

   Address:                                                 City:                       State:

   Country:                                                 Postal Code:

   Telephone:                      Ext:           Fax:                       Email:



  Chief Physicist

   Name:

   Address:                                                 City:                       State:

   Country:                                                 Postal Code:

   Telephone:                      Ext:           Fax:                       Email:



  Clinical Physicist/Dosimetrist

   Name:

   Address:                                                 City:                       State:

   Country:                                                 Postal Code:

   Telephone:                      Ext:           Fax:                       Email:


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                                                                                     CONFIDENTIAL



  Radiation Oncology Personnel – cont’d

  Principal Investigator - Clinical Site

   Name:

   Address:                                             City:                   State:

   Country:                                             Postal Code:

   Telephone:                         Ext:       Fax:                  Email:



  Responsible Radiation Oncologist - Clinical Site

   Name:

   Address:                                             City:                   State:

   Country:                                             Postal Code:

   Telephone:                         Ext:       Fax:                  Email:




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                                                                                                   CONFIDENTIAL




                                  SITE STAFF INFORMATION FORM
                                             (All fields are required)

Date:                      Investigator’s NCI Identification No.:           NCI CTEP Institution Code:

Name of Staff Member (First, Last):                                         Degree(s) [e.g., MD, PhD, RN]:

Institution Name:                                                 Department:

Address:                                                          City:                        State:

Country:                                                          Postal Code:

Telephone:                 Ext:                   Fax:                             Email:

Area of Specialty (Investigators ONLY):
   Lymphoma                                  Hematology/Oncology                 Radiation/Oncology
   Human Papilloamavirus (HPV)               Pathology                           Other, specify:
   Kaposi’s Sarcoma                          Cytogenics
   Immunology                                Surgery
                                             Epidemiology

Indicate the Working Group(s) you would like to join (Investigators ONLY):
   Kaposi’s Sarcoma                    Laboratory
   Lymphoma                            Non AIDS-Defining Cancer
   International                       Pharmacology
   HPV

Role as Part of AIDS Malignancy Consortium (AMC):
   Principal Investigator                                 Data Manager
   Sub-Investigator                                       Surgeon
   Pharmacist                                             Laboratory Technician
   Clinical Research/Study Coordinator                    Regulatory Personnel
   Clinical Research Nurse                                Community Advisory Board Representative
   Pathologist                                            Other, specify:
   Radiologist


For Principal Investigator ONLY:

Select One Does Principal Investigator have a private practice?       NCI Site Identification No.:
Select One If “Yes,” has the Investigator submitted an Agreement for Independent Investigator (AII)?
Select One Certification on Protection of Human Subject Training?




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  STATEMENT OF FINANCIAL, EQUITY, AND INTELLECTUAL PROPERTY INTERESTS

Name of AMC Member (Please Print):                                            Date of Statement:

Primary Institution:


Position I hold within the AMC that requires submission of this form:

1. PAST OR PRESENT INTERESTS*: Please list below any pharmaceutical, diagnostic, biologic, or related software
company you or your family member(s) have or have had $10,000 or more of either industry grant or contract, financial, equity,
or intellectual property interests in the 365 days prior to the date of this document, as defined by SOP “AIDS Malignancy
Consortium (AMC) Financial Disclosure Guidelines.”
                                                         TYPE OF INTEREST (PLEASE CHECK )
          NAME OF COMPANY                                                                                RESEARCH OR
                                                                               INTELLECTUAL
                                              FINANCIAL          EQUITY                                 SERVICE GRANTS
                                                                                 PROPERTY
                                                                                                        AND CONTRACTS




2. ANTICIPATED FUTURE INTERESTS*: Please list below any pharmaceutical, diagnostic, biologic, or related software
company you or your family member(s) expect to have $10,000 or more of either industry grant or contract, financial, equity, or
intellectual property interests in the future, as defined by SOP “AMC Financial Disclosure Guidelines.”
                                                         TYPE OF INTEREST (PLEASE CHECK )
         NAME OF COMPANY                                                                                 RESEARCH OR
                                                                               INTELLECTUAL
                                              FINANCIAL          EQUITY                                 SERVICE GRANTS
                                                                                 PROPERTY
                                                                                                        AND CONTRACTS




3. KNOWN FUTURE STOCK OPTIONS/PATENT RIGHTS: Please list any known stock options and/or patent rights in a
pharmaceutical, diagnostic, biologic, or related software company you or your family member(s) have, regardless of the current
value as defined by SOP “AMC Financial Disclosure Guidelines.”
                                                           PLEASE CHECK 
         NAME OF COMPANY                       KNOWN FUTURE
                                                                       PATENT RIGHTS
                                               STOCK OPTIONS




4. The statements I have made are true, complete, and correct. I give my permission to disclose this information to appropriate
AMC Leaders and anyone who specifically requests it in writing.


         Signature                                                                               Date

*Required under the Food and Drug Administration (FDA) regulations, investigational new drug application regulation
21CFR312, if interest amount exceeds $25,000, then it is necessary to denote >$25,000 on this form.

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      GUIDELINES FOR COMPLETING STATEMENT OF FINANCIAL, EQUITY,
                AND INTELLECTUAL PROPERTY INTERESTS

On the attached AMC Statement of Financial, Equity, and Intellectual Property Interests, please refer to
the following categories when listing the activities for which you receive significant financial
compensation, have significant equity interest, or have intellectual property interest.

“Significant” is defined as an interest of more than $10,000. Disclosure of significant interests should be
for the prior 365 days and for any expected interests that might accrue in the following 365-day period.

Required under the Food and Drug Administration (FDA) regulations, investigational new drug
application regulation 21CFR312, if you check () any box indicating interest > $10,000 and the amount
exceeds $25,000, then it is necessary to denote >$25,000 on the AMC Statement of Financial, Equity, and
Intellectual Property Interests Form:

    Salary
    Consultant fee, direct and indirect
    Lecture fee, direct and indirect
    Equipment
    Gift
    Honorarium
    Research grant (non-government)…check box, do not specify amount
    Research contract (non-government) …check box, do not specify amount
    Service grant (non-government)…check box, do not specify amount
    Service contract (non-government)…check box, do not specify amount
    Membership on scientific/clinical advisory board
    Stock owned by you or a family member
    Stock option owned by you or a family member
    Patent
    Pending patent
    Patent held by third party
    Copyrights
    Royalties




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                                                                                           CONFIDENTIAL




                                  ADHERENCE STATEMENT

The AMC is comprised of individuals whose ethical standards build the foundation for the research
conducted. The highest standards of integrity are expected among all members of the Group. The AMC
Data Safety and Monitoring Plan follows the NCI Data Safety Monitoring Guidelines for Clinical Trials
(available on the agency’s web page [www.nci.nih.gov]). To gain the utmost quality of scientific
research, the AMC and its members are committed to the prevention and detection of research misconduct
in clinical trials. All data are audited internally for data inconsistencies and are periodically audited by
AMC monitors during external site visits. Furthermore, all members are obliged to communicate concerns
about research misconduct to the Group. The primary purpose of monitoring a clinical trial is to ensure
the safety and well-being of the specific patients entered on the trial. All members of the AMC are
dedicated to this purpose. Submission of falsified data by member sites will not be tolerated and will be
reported according to Federal guidelines.

The AMC Operations Center oversees the development of all clinical protocols, including protocol
activation and the production of all protocol documents, and is responsible for the data management and
database activities involved in all AMC clinical protocols. Their duty is to ensure that the Group,
consisting of all AMC institutions, investigators and operations personnel are in compliance with the
Office for Human Research Protections (OHRP) regulations, FDA regulatory requirements, and GCP
guidelines. For the AMC to be successful in its mission, the participating sites must be committed to the
consortium and must perform at an effective level in accordance to these regulations and guidelines.

By completing the registration materials to become an AMC Affiliated site or Enrolling site, you are
agreeing to:
   Abide by the AMC Data and Safety Monitoring policy.
   Adhere to FDA regulatory requirements and GCP guidelines.
   Supply a copy of the Investigator’s most recent curriculum vitae to the AMC Operations Center,
    stating whether or not s/he is board certified and ensure that any changes that should occur be
    reflected in updated curriculum vitae.
   Provide new information regarding personnel at the AMC institution to the AMC Operations Center
    in a timely manner, including laboratory certifications, licensure of site personnel, and changes
    occurring to the status/role of any personnel involved in an AMC-sponsored clinical trial (via the Site
    Staff Information Form).
   To notify the AMC Operations Center of lapses in required certifications and/or scientific
    misconduct.

By signing below, you are in stating that you have read the AMC Data and Safety Monitoring Policy and
agree to adhere to the policies outlined by the AMC in regards to becoming one of its members.


_________________________________________                 ___________________
Signature of Principal Investigator                       Date


_________________________________________
Printed Name of Principal Investigator



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                               AMC DATA SAFETY MONITORING PLAN

Monitoring the Progress of Trials and the Safety of Participants

All AMC protocols follow the Cancer Therapy Evaluation Program (CTEP) guidelines for reporting of
adverse events. All adverse events that meet the expedited reporting requirements of the National Cancer
Institute (NCI) are reported to the Investigational Drug Branch (IDB) of the NCI via the Adverse Event
Expedited Reporting System (AdEERS) web application. All expedited adverse event reports are also
required to be submitted to the local Institutional Review Board (IRB) of the reporting institution. If NCI
holds the IND or no IND is required for a study, the AMC sites report serious adverse events directly to
the AMC Operations and Data Management Center (ODMC) via AdEERS. In some instances, the AMC
sites may report serious adverse events directly to the commercial sponsor holding the IND who will then
in turn report to the AMC ODMC. However, most AMC protocol require that sites report all serious
adverse events via AdEERS with the AMC ODMC forwarding a copy of the report to the sponsor.
Unless an AMC protocol specifies an alternate plan for the review and submission of serious adverse
events, all serious adverse events received by the AMC ODMC will be reviewed by the AMC Medical
Monitor at the AMC ODMC prior to submission to NCI and the sponsor. For protocols for which the
IDB does not have an assigned drug monitor to review serious adverse event reports, in the event of
disagreement between the reporting physician and the AMC Medical Monitor regarding the attribution of
the event to the investigational agent(s) (i.e., determination of whether the relationship is unrelated,
unlikely, possible, probable, or definite), the AMC Medical Monitor will provide the final determination
of the relationship.

The AMC ODMC provides a listing of serious adverse events to the Protocol Chair and Co-chair(s) for
review on a regular basis. The AMC ODMC compiles these events in a tabular format and posts them on
the password-protected section of the AMC web site. The AMC web site is accessible to all AMC
investigators, co-investigators, and their staff. Email notification that this information is available on the
web site will be sent to all site PIs. It is the responsibility of each site to provide this information to their
respective IRBs, if required by their IRB. For blinded studies, the serious adverse events are reviewed
and tabulated without treatment assignment.

Accrual summaries for each AMC trial are updated nightly on the password-protected section of the
AMC web site. The progress of each AMC trial is reviewed regularly by the Protocol Chair and also by
the appropriate disease-oriented Working Group during scheduled conference calls. For phase I dose
escalation trials, dose escalation (or dose de-escalation) is based on the rules in the protocol and the
Protocol Chair and Group Statistician determine whether these criteria have been met. For phase II trials,
stopping the trial for toxicity or efficacy, or suspending enrollment pending observation of responses in a
multi-stage phase II trial, is based on meeting criteria stated in the protocol, and the Protocol Chair and
Group Statistician determine whether these criteria have been met.

For phase III trials, the AMC has formed an independent Data Safety and Monitoring Committee
(DSMC). Voting members of the DSMC are physicians, statisticians, and a patient advocate. All voting
members are from outside the AMC. Non-voting members are the NCI scientific project officers and an
NCI statistician. The AMC Data Safety and Monitoring Committee reviews AMC phase III studies in
accordance with the National Cancer Institute’s Policy for Data Safety and Monitoring. Confidential
reports of all phase III trials are prepared by the AMC Group Statistician with support from the AMC
ODMC. A written report containing the current status of each trial monitored, and when appropriate, any
toxicity and outcome data, are sent to DSMC members by the AMC ODMC allowing sufficient time for
DSMC members to review the report prior to the meeting. This report addresses specific toxicity
concerns as well as concerns about the conduct of the trial. The report may contain recommendations for

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consideration by the DSMC concerning whether to close the trial, report the results, or continue accrual or
follow-up.

The results of each DSMC meeting are summarized in a formal report sent by the DSMC Chair to the
Group Chair and AMC ODMC within 1 week of the meeting. The DSMC report contains
recommendations on whether to close each study reviewed, whether to report the results, and whether to
continue accrual or follow-up. A primary recommendation (e.g., continue with no change; recommended
or required modification; stop) must be included in the document. The Group Chair is then responsible for
notifying the Protocol Chair and relevant Disease-oriented Working Group Chair before the
recommendations of the DSMC are carried out. In the unlikely event that the Protocol Chair does not
concur with the DSMC, then the NCI Division Director or designee must be informed of the reason for
the disagreement. The Study Chair, relevant Disease-oriented Working Group Chair, Group Chair,
DSMC Chair and NCI Division Director or designee will be responsible for reaching a mutually
acceptable decision about the study. CTEP approval of a formal amendment will be required prior to any
implementation of a change to the study.

Following a DSMC meeting, a summary of the serious adverse events reported to the DSMC is posted to
the AMC web site. It is each site’s responsibility for conveying this information to its IRB.

Plans for Assuring Compliance with Requirements Regarding the Reporting of Adverse Events
(AE)

For trials monitored by the NCI’s Clinical Data Update System (CDUS), adverse event information is
transmitted electronically to NCI on a quarterly basis. For trials monitored by NCI’s Clinical Trials
Monitoring Service (CTMS), adverse event information is transmitted electronically to NCI every two
weeks.

Plans for Assuring that any Action Resulting in a Temporary or Permanent Suspension of an NCI-
funded Clinical Trial is Reported to the NCI Grant Program Director Responsible for the Grant

In the event that termination of the trial or major modification to the protocol is under consideration, the
Protocol Chair will convene the AMC Data Coordinator and Disease-oriented Working Group Chair by
conference call to discuss the options. For phase I and II trials, the Protocol Chair also has the option of
asking the AMC DSMC to review the study. The AMC ODMC will inform the CTEP Protocol
Information Office (PIO) when studies are temporarily or permanently closed. The Cancer Treatment and
Evaluation Program (CTEP) of the National Cancer Institute (NCI) must approve all protocol
amendments prior to distributing to the AMC sites.

Plans for Assuring Data Accuracy and Protocol Compliance

All study data for AMC clinical trials are entered directly by AMC site staff into AdvantageEDCSM (a
web-based data entry and enrollment system). During data entry, the system performs validation checks
on many fields and performs consistency checks between select fields. Range checks are placed on each
field to eliminate entry of out-of-range values. Edit check programs are run on the database on a set
schedule to identify and resolve inconsistencies between forms or data collected at different points in
time. AMC ODMC staff routinely interacts with site staff to resolve any data problems.

In accordance with NCI guidelines, the AMC ODMC conducts monitoring visits at the AMC sites to
evaluate compliance with regulatory issues, and to review data for specific cases by checking source
documents. These reports are sent to the site Principal Investigator and to the NCI. In the event that
major violations are identified, sites are asked to provide a plan to correct deficiencies within 30 days. If


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needed, a repeat site visit is conducted. In the event that a site does not correct deficiencies in a pre-
determined time frame, the AMC Executive Committee has the option of taking action against the site.
Possible actions include, but are not limited to, suspending enrollment of new patients to AMC trials until
deficiencies are corrected; recommending a decrease in funding to the site; and requiring specific training
for site investigators or staff members.




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